Spirit® Hydrocolloid Adhesive Sheath 39302Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00801741071331), received between Jul 9, 2018 and May 24, 2024 — classified as 13 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SPIRIT CONDOM MALE EXTERNAL CATHETER PATIENT HAD TO APPLY TAPE TO HOLD IT ON ALL NIGHT AND THAT WAS CAUSING IRRITATION WHEN REMOVED. PER ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER FOLLOW UP ON 07MAY2024, IT WAS REPORTED THAT SOME OF THE CATHETERS WOULD NOT STAY IN PLACE ONCE APPLIED. THEY ALSO CAUSE A BIT OF IRRITATION IN THE CUSTOMER'S PRIVATE AREA. CUSTOMER WAS PRESCRIBED AN ANTIBIOTIC CREAM TO APPLY IN THE AFFECTED AREA.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19392388 ↗
• MalfunctionJun 30, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE NOT SEALED PROPERLY AND WAS LEAKED . PER ADDITIONAL INFORMATION RECEIVED ON 13JUNE2023, IT WAS REPORTED THAT THE STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237139 ↗
• InjuryMay 22, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINS IN THEIR KIDNEYS AND A BLADDER INFECTION AFTER TRYING THE INTERMITTENT CATHETER. IT WAS UNKNOWN IF THE DEVICE CAUSED THE BLADDER INFECTION AND UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE BLADDER INFECTION AT THIS TIME. PER FOLLOW UP VIA PHONE (B)(6) 2023, THEY RECEIVED CATHETERS THAT WERE TOO SMALL FOR THEIR ANATOMY THAT CAUSED AN INFECTION. THEY HAD SINCE RECEIVED BIGGER ONES THAT WORK MORE EFFECTIVELY. CUSTOMER WAS IN THE HOSPITAL FOR 3 DAYS AND RECEIVED ANTIBIOTICS FOR THE INFECTIONS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16973276 ↗
• InjuryMay 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT USED SPIRIT CATHETERS AND BAGS. THE PATIENT WAS HOSPITALIZED WITH AN INFECTION AND HIGH FEVER AND URINARY TRACT INFECTION WITH BLOOD THEM URINE. THE CUSTOMER STATED WAS NOT SURE IF IT IS DUE TO CONDOM CATHETER, BUT THEY HAD ISSUES WITH CATHETERS TWISTING. THE HOSPITAL USING SOMETHING TO HOLD CATHETERS IN PLACE. THE REPRESENTATIVE LET CUSTOMER KNOW ASK WHAT THEY ARE USING. THE REPRESENTATIVE MIGHT BE USING A STAT LOCK AND PROVIDED PRICING. THERE WAS NO MENTION IF LOT INFORMATION WAS AVAILABLE. IT WAS UNKNOWN IF THE DEVICE CAUSED THE INFECTION AND UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION AT THIS TIME.

  Patient problems: Fever; Hematuria; Unspecified Infection; Urinary Tract Infection

  MAUDE report 16885462 ↗
• MalfunctionApr 26, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THEY WERE HARD TO REMOVE THE MALE EXTERNAL CATHETER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817912 ↗
• MalfunctionNov 18, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES ON REMOVING ADHESIVE MALE EXTERNAL CATHETERS, THEY HAD TO TAKE A SHOWER AND USE SOAP FOR REMOVAL. THE REPRESENTATIVE LET CAREGIVER TO KNOW THERE ARE CONDOM CATHETER WITH LESS ADHESIVE AREA, WARM WATER WAS RECOMMENDED TO HELP REMOVE. THE PATIENT COULD ALSO USE ADHESIVE REMOVE THAT WOULD BE AN ITEM AND THEY ALSO HAVE NATURAL CATHETERS. AS PER FOLLOW UP VIA PHONE ON 16NOV2022, IT WAS REPORTED THAT THE CUSTOMER HAS A HARD TIME IN REMOVING THE CATHETERS AFTER USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825353 ↗
• MalfunctionJul 6, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS FROM THE LAST BOX OF SUPPLIES WERE NOT STICKING. PER SAMPLE EVALUATION FROM INVESTIGATOR VIA EMAIL ON 16JUN2022, A STRONG ADHESIVE RESULT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14930666 ↗
• MalfunctionJul 5, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ALL 90 MALE EXTERNAL CATHETERS WERE SO STICKY AND THAT THE PATIENT COULD NOT ROLL THEM DOWN. IT WAS STATED THAT IT SEEMED AS THE CATHETERS WERE RUINED IN THE HEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916461 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TWO URINARY TRACT INFECTIONS SINCE THEY SAW LIBERATOR REPRESENTATIVE OR WITHIN THE LAST 12 MONTHS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 14309519 ↗
• MalfunctionMar 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE NOT STICKING PROPERLY AND THAT THE CATHETERS WERE ALREADY UNROLLED WIDELY. THE PATIENT STATED THAT THREE PACKAGES FROM THE SAME LOT WERE AFFECTED. PER SAMPLE EVALUATION FROM INVESTIGATOR VIA EMAIL ON 04FEB2022, A STRONG ADHESIVE RESULT WAS FOUND IN THE MALE EXTERNAL CATHETER DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636007 ↗
• InjuryDec 29, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION BY USING THE MALE EXTERNAL CATHETERS AND STATED THAT THE PATIENT WAS SENT TO THE HOSPITAL. THE PATIENT REPORTED THIS ISSUE WITH TWO DIFFERENT PRODUCT CATALOG NUMBERS (39302 AND 39303). THEY WERE NOT SURE WHICH PRODUCT HAD CAUSED THE ISSUE, AND THE PATIENT SAID SOMETHING ABOUT THE URINE STICKS. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13114986 ↗
• InjuryDec 29, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION BY USING THE MALE EXTERNAL CATHETERS AND STATED THAT THE PATIENT WAS SENT TO THE HOSPITAL. THE PATIENT REPORTED THIS ISSUE WITH TWO DIFFERENT PRODUCT CATALOG NUMBERS (39302 AND 39303). THEY WERE NOT SURE WHICH PRODUCT HAD CAUSED THE ISSUE, AND THE PATIENT SAID SOMETHING ABOUT THE URINE STICKS. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13114896 ↗
• MalfunctionDec 9, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE COMPLAINANT INQUIRED IF THERE WAS SOMETHING ELSE TO HELP TO REMOVE THE MALE EXTERNAL CATHETER BESIDES THE SPRAY. THE REPRESENTATIVE GAVE SOME TROUBLESHOOTING TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968999 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STICKY AND THEY WERE NOT WORKING. AS PER ADDITIONAL INFORMATION VIA EMAIL ON 23OCT2021, STATED THAT THE ISSUE REFERS TO BOTH THE PRODUCTS (39302 AND 39304).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781005 ↗
• MalfunctionOct 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT TRIED USING A 29MM MALE EXTERNAL CATHETER AND IT GOT STUCK. THE PATIENT COULD NOT GET THE CATHETER OFF AND THOUGHT THAT THEY HAD TO GO TO THE EMERGENCY ROOM. ALSO STATED THAT THE PATIENT HAD PAIN IN THE PENIS FOR SEVERAL DAYS AFTER. THE MENTIONED CATALOG NUMBERS WERE 35302, 37302 AND 39302. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 12722183 ↗
• MalfunctionOct 26, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE STICKING TO THE PATIENT SKIN AND CAUSED DISCOMFORT. PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 12697189 ↗
• MalfunctionJun 15, 2021Nonstandard Device; Device Handling Problem; Nonstandard Device; Device Handling Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER STUCK TO THE PATIENT AND EXPERIENCED PAIN. IT WAS FURTHER REPORTED THAT THE PATIENT WAS MISSING THE TUBE IN IT. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA PHONE ON (B)(6) 2021 THE CUSTOMER RECEIVED A REPLACEMENT TUBE FOR THE MISSING LEG BAG TUBE. THE CUSTOMER HAD A MALE EXTERNAL THAT STUCK TO THE SKIN AND HURT WHILE REMOVING. THE PATIENT LEARNED THAT WEARING THEM LONG ENOUGH ALLOWED THE ADHESIVE TO BE LESS STRONG OVER THE TIME. AND ALSO STATED THAT THE CUSTOMER SWITCHED TO NON ADHESIVE MALE EXTERNAL CATHETER (38304) BUT IT WOULD NOT STAY IN PLACE. THE CUSTOMER HAD 29 UNUSED MALE EXTERNAL CATHETERS TO RETURN. THE CUSTOMER HAD A LEG BAG THAT RETAINED URINE ODOR EVEN AFTER CLEANING. PER CUSTOMER VIA PHONE ON (B)(6) 2021 THE PRODUCT (32304) WAS WORN ABOUT A WEEK OR TWO BEFORE REMOVING AND STILL LEAVE STICKY RESIDUE ON THE PENIS WHICH WAS DIFFICULT TO REMOVE.

  Patient problems: Pain

  MAUDE report 11999678 ↗
• InjuryMay 5, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT RECENTLY HAD A URINARY TRACT INFECTION, AND ALTHOUGH THE PATIENT DID NOT KNOW THE CAUSE OF URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11778504 ↗
• InjuryApr 26, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC TYPE REACTION FROM THE LAST ORDER OF MALE EXTERNAL CATHETER. THE UROLOGIST HAD PRESCRIBED A RASH CREAM AND THE PATIENT FELT BETTER. PER FOLLOW UP VIA PHONE ON 05APR2021 THE CUSTOMER USED 1 PERCENT CLOTRIMAZOLE BETAMETHASONE DIPROPIONATE PRESCRIPTION CREAM ON THE AREA. THE CUSTOMER WAS NO LONGER USING THE CATHETERS AND HAD NO FURTHER ISSUES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11724732 ↗
• MalfunctionApr 2, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD AN UNKNOWN DEFECT. PER FOLLOW UP ON 15MAR2021 THE CUSTOMER HAD A BREAKDOWN ON THE PENIS BY THE USE OF THE MALE EXTERNAL CATHETER AND STOPPED USING THE CATHETER. THE CUSTOMER USED HONEY MEDICATION RECEIVED FROM THE DOCTOR IN THE AREA AND IT CLEARED UP AFTER ABOUT A WEEK. THE CUSTOMER STARTED USING THE CATHETERS AND AGAIN THE BREAKDOWN WAS REOCCURRED. IT WAS STATED THAT THE CUSTOMER WAS HAVING THIS PROBLEM ON AND OFF SINCE 2018.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11607961 ↗
• MalfunctionApr 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SAMPLES OF THE MALE EXTERNAL CATHETERS WITH ADHESIVE WERE DIFFICULT TO REMOVE. PATIENT STATED THAT USING A SOAPY WATER DID NOT REALLY HELP WITH REMOVING THESE EXTERNALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607439 ↗
• MalfunctionFeb 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INCONSISTENCY WITH CATHETERS; SOME HAVE TOO MUCH ADHESIVE, WHILE OTHERS HAVE NO ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11302518 ↗
• MalfunctionFeb 7, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID AFTER TRYING THE SPIRIT MALE EXTERNAL CATHETER SEVERAL TIMES AND FOLLOWING THE INSTRUCTIONS FOR APPLICATION AND REMOVAL. THE PATIENT GENTLY ROLLED THE CATHETER OFF THE PENIS AND APPLIED A WET WASHCLOTH AROUND THE CATHETER TO HELP IT LOOSEN, BUT STILL THE PATIENT FOUND IT EXTREMELY DIFFICULT TO REMOVE, WHICH RESULTED IN A SEVERE IRRITATION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Irritation; Skin Inflammation/ Irritation

  MAUDE report 11290524 ↗
• InjuryJan 20, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION BY USING THE MALE EXTERNAL CATHETER. IT WAS NOTED THAT THE PATIENT WAS CONSULTING THE PHYSICIAN AT THAT TIME. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11203370 ↗
• MalfunctionJan 7, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH GLUE ON THE MALE EXTERNAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11132033 ↗